Manufacturer registered with FDA
Accumedix, Inc.
Libertyville, IL, United States. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 19
- 510(k) clearances
- 0as applicant
- Markets registered in
- 25 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Accumedix, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Accumedix, Inc. | 8 device types | — | Below |
| Canada | Health Canada | Registration holder | ACCUMEDIX INC. | 5 | 2015–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Accumedix, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Bio Conus, Bio Max, and Bio Quattro Implant SystemsBlue Sky Bio Dental ImplantBlue Sky Bio Pterygoid Implants and AbutmentsDouble Hex Implant SystemOne Stage Implant SystemZygomatic Implant System | 2008 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Bio Conus, Bio Max, and Bio Quattro Implant SystemsBlue Sky Bio CAD-CAM AbutmentsBlue Sky Bio Dental ImplantBlue Sky Bio Pterygoid Implants and AbutmentsDouble Hex Implant SystemZygomatic Implant System | 2009 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Flycast Technologies Dental BandPinkband Dental Band | 2008 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Dental Implant Accessory Instruments | 2021 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Blue Sky Bio Impression Copings | 2009 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Blue Sky Bio Dental Bur | 2009 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Blue Sky Bio Implant Accessories | 2008 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Blue Sky Bio TAD | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ACCUMEDIX, INC.FDA reg. 1424785 | Libertyville, IL, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9046081). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.